15 08, 2022

Annex 21 in Effect from August 21st 2022

By |2022-08-22T09:07:54+00:00August 15th, 2022|Featured, Industry News, News|

The new Annex 21, The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, is now in effect. Are you prepared for it's changes? There are a number of key requirements for a Manufacturing Import Authorisation (MIA) holder when

27 07, 2022

Extension of the comment period by FDA

By |2022-10-18T16:03:00+00:00July 27th, 2022|Featured, General News, Industry News|

FDA Proposed Rule "National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers" In February 2022, the FDA has announced the availability of the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)". The proposed rule sets national licensing standards for both federal and

12 10, 2020

MHRA (GxP) Inspections during COVID19

By |2021-10-13T14:21:00+00:00October 12th, 2020|General News|

The COVID19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. MHRA understands the impact of its work on industry, NHS and patients. This is not just in terms of our regulatory support to bring new technologies and products quickly and safely to market, but also the personnel and

5 10, 2020

Regulations for Pharmaceuticals Post Brexit

By |2021-10-13T14:30:17+00:00October 5th, 2020|General News|

The European Commission has published a Communication to prepare for the end of the transition period. The document is appropriately entitled "Getting ready for changes - Communication on readiness at the end of the transition period between the European Union and the United Kingdom". Far-reaching changes and consequences are therefore to be expected after 1

30 09, 2020

Complying with new GDP requirements

By |2021-10-13T14:27:04+00:00September 30th, 2020|General News|

In an ever changing and complex industry the role of the Responsible Person has developed and grown over the past 10 years as the focus of regulatory bodies have placed a higher level of scrutiny on how GDP principals are implemented and applied for Wholesale Distributors. Initially the main areas of compliance for

29 09, 2020

QP Responsibilities

By |2021-10-13T14:27:36+00:00September 29th, 2020|General News|

MIAS Pharma provides QP services for commercial and investigational medicinal products. Our QPs have experience in oversight and release of multiple types of products. Each type of product has it's own specific properties and challenges, which determines what approach should be taken to provide the best solutions. Sterile products have to be free

21 09, 2020

Pharma Industry Awards 2020

By |2021-10-14T10:17:33+00:00September 21st, 2020|General News|

We’re pleased to announce that MIAS Pharma Ltd has been shortlisted for Pharma Supplier of the Year in this years Pharma Industry awards. We look forward to a great evening and catching up with our peers and suppliers.Since launching in 2014, the Pharma Industry Awards has established itself as the benchmark for those demonstrating excellence in the pharma

24 09, 2019

Good Distribution Practice (GDP): Issue of Theft

By |2019-09-24T14:56:53+00:00September 24th, 2019|General News|

The wholesale distribution of medicinal products and active substances is an important activity. The quality and the integrity of medicinal products can be affected by a lack of adequate control. The quality, safety and efficacy of medicinal products depend on a whole range of different factors. The most important factors are that

19 09, 2019

Pharma giant tackling counterfeit drugs using blockchain

By |2021-08-01T14:55:41+00:00September 19th, 2019|Industry News|

MIAS PHARMA UPDATEFighting counterfeit drugs with blockchain technology… The Asia-Pacific pharmaceutical giant Zuellig pharma is using a blockchain platform by SAP to assist consumers identify the medicines place of origin. With 1 in 10 medicinal products that are used in developing countries deemed fake, there is a substantial need to eradicate counterfeit drugs that could

17 09, 2019

Brexit Preparedness Checklist – HPRA

By |2019-09-17T11:32:15+00:00September 17th, 2019|Industry News|

The Health Products Regulatory Authority (HPRA) have released a 'Brexit Preparedness' checklist. The checklist has been divided into four parts which include:  Supply Chain  Customs  Medicines Regulatory Compliance Medical Devices Supply Chain In relation to the supply of medicines and medical devices, companies are requested to: Map your supply chain to

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